February 13, 2008
FDA Recalls Fentanyl Painkiller Patches
Patches sold in the United States under the brand name Duragesic which contain the painkiller fentanyl were recalled on Tuesday.
The recall includes all 25-microgram-per-hour patches that have expiration dates on or before December 2009.
The cause of the recall is a possible cut in the lining of the reservoir where the drug is stored in gel form. A gel leak into the drug's packaging could result in difficulty breathing and a potentially fatal overdose.
The cut in the patch can be seen when the foil pouch container is opened. Any damaged patch should be flushed down the toilet, and the handler of the drug should be immediately rinsed with water, but not washed with soap.
The powerful drug is used with patients such as cancer patients, who are experiencing chronic pain and are used to narcotics. Therefore, it can cause trouble breathing in people not used to this class of painkillers. In December, the FDA put out its second warning in two years about the dangers of misusing the powerful drug.
PriCara estimates that two patches out of every million included in the recall have the defect that causes the leak, according to Associated Press.
For details on Duragesic patches sold by PriCara, call 800-547-6446. For details on generic fentanyl patches sold by Sandoz, call 800-901-7236.
The recalled patches were also sold in Canada under the Duragesic brand by Janssen-Ortho Inc. and generically by Ranbaxy Laboratories Ltd.
All of the patches were manufactured by PriCara affiliate ALZA Corp. PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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